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Study of Combination Therapy With SYR-322

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01521962
First received: January 26, 2012
Last updated: November 12, 2013
Last verified: November 2013

January 26, 2012
November 12, 2013
February 2012
March 2013   (final data collection date for primary outcome measure)
Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value) [ Time Frame: Baseline and Week 12 ]
Same as current
Complete list of historical versions of study NCT01521962 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study of Combination Therapy With SYR-322
A Phase 3 Study to Investigate the Efficacy and Safety of SYR-322 When Used in Combination With Insulin Preparation in Subjects With Type 2 Diabetes in Japan

To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Diabetes Mellitus
  • Drug: Alogliptin
    Alogliptin tablets
    Other Name: SYR-322
  • Drug: Insulin
    Insulin injection
  • Experimental: SYR-322 (Alogliptin) QD
    SYR-322 25 mg, orally.
    Intervention: Drug: Alogliptin
  • Placebo Comparator: Insulin
    injection
    Intervention: Drug: Insulin
Kaku K, Mori M, Kanoo T, Katou M, Seino Y. Efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes: a randomized, double-blind, 12-week, placebo-controlled trial followed by an open-label, long-term extension phase. Expert Opin Pharmacother. 2014 Oct;15(15):2121-30. doi: 10.1517/14656566.2014.956722. Epub 2014 Sep 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. The subject is an outpatient.
  2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

  1. The subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
  2. The subject is considered ineligible for the study for any other reason by the investigator or subinvestigator.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01521962
SYR-322/CCT-901, U1111-1127-1525, JapicCTI-121736
Not Provided
Takeda
Takeda
Not Provided
Study Director: Senior Manager Takeda
Takeda
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP